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Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from September 2011 to December 2013. The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to generate additional data on the diagnostic efficacy, reliability and safety of Dotarem in Magnetic Resonance (MR) mammography.
Diagnostic efficacy was assessed on the basis of image quality (5-stage scale from "excellent" to "very poor"), diagnosis and cytology test result. Safety was assessed on the basis of the frequency and seriousness of adverse drug reactions observed following the injection of Dotarem.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All included patients | All included patients underwent MR mammography with Dotarem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR mammography with Dotarem | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality | Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor". | During MRI procedure |
| Ability to Make a Diagnosis | Ability to make a diagnosis was evaluated by answering "yes" or "no" to the question "Did the examination permit a diagnosis ?" | During MRI procedure |
| Diagnostic Results (Percentage of Patients Per Diagnosis) | Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient. | During MRI procedure |
| Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient. | During MRI procedure |
| Frequency of Adverse Drug Reactions | The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered. | From the beginning of the MR mammography procedure to 30-60 min after |
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Inclusion Criteria:
Exclusion Criteria:
-
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Adult and pediatric patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem
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| ID | Title | Description |
|---|---|---|
| FG000 | All Included Patients | All included patients underwent MR mammography with Dotarem. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Included Patients | All included patients underwent MR mammography with Dotarem. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Image Quality | Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor". | Image quality was missing for 16 patients. | Posted | Count of Participants | Participants | During MRI procedure |
|
|
From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Included Patients | All included patients underwent MR mammography with Dotarem. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oliver Heine, MD, Radiology & Scientific Affairs Manager | Guerbet GmbH | +49 6196 76250 | oliver.heine@guerbet-group.com |
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| ID | Term |
|---|---|
| C072417 | gadoterate meglumine |
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| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Gender was missing for 43 patients. | Count of Participants | Participants |
|
| Menopausal status | Menopausal status was recorded before MR mammography. | Menopausal status was missing for 31 patients. | Count of Participants | Participants |
|
| Risk factors | Risk factors were recorded before MR mammography. | Risk factors were missing for 270 patients. | Count of Participants | Participants |
|
|
| Primary | Ability to Make a Diagnosis | Ability to make a diagnosis was evaluated by answering "yes" or "no" to the question "Did the examination permit a diagnosis ?" | Ability to make a diagnosis was missing for 2 patients. | Posted | Count of Participants | Participants | During MRI procedure |
|
|
|
| Primary | Diagnostic Results (Percentage of Patients Per Diagnosis) | Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient. | Diagnosis was achieved in 1523 patients but results were missing for 4 patients. | Posted | Count of Participants | Participants | During MRI procedure |
|
|
|
| Primary | Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient. | A cytology test was performed in 232 patients. | Posted | Count of Participants | Participants | During MRI procedure |
|
|
|
| Primary | Frequency of Adverse Drug Reactions | The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered. | Posted | Number | Adverse drug reactions | From the beginning of the MR mammography procedure to 30-60 min after |
|
|
|
| 0 |
| 1,537 |
| 1 |
| 1,537 |
| 4 |
| 1,537 |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting projectile | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
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| Title | Measurements |
|---|
|
| Other |
|
| Invasive ductal carcinoma |
|
| Bilateral focal pathological findings |
|
| Carcinoma in situ |
|
| Extensive intraductal component |
|
| Title | Measurements |
|---|
|
| Intraductal carcinoma |
|
| Fibroadenoma |
|
| Mucinous carcinoma |
|
| Inflammatory carcinoma |
|
| Papilloma |
|
| Medullary carcinoma |
|
| Invasive papillary carcinoma |
|
| Tubular carcinoma |
|